SAN JOSE, Calif., May 11, 2015 /PRNewswire/ — SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System, a minimally invasive surgical (MIS) device indicated
for fusion for certain disorders of the sacroiliac (SI) joint, announced that results from the INSITE study, presented at this year’s Annual International Society for the Advancement of Spine Surgery (ISASS) meeting in San Diego on April 15th, was awarded the Leon L. Wiltse Award for Best Overall Paper by the ISASS meeting program committee. The award, sponsored by Dr. and Mrs. Hansen Yuan, is voted on by the committee chairs each year and is based on a combination of quality of submitted abstract and podium presentation. This years’ paper was chosen from over 450 submitted abstracts. The paper, presented by Peter Whang, MD, FACS, principal investigator of the INSITE trial, was titled: Minimally Invasive SI Joint Fusion Using Triangular Implants vs. Non-surgical Management of Chronic SI Joint Dysfunction: Results of a Prospective Multicenter Randomized Trial. Six-month results on the 148 patients enrolled in INSITE were published in the International Journal of Spine Surgery (IJSS) Journal earlier this year. Results showed that the iFuse Implant System provided superior outcomes for SI joint pain, disability and quality of life vs. non-surgical management in patients with SI joint dysfunction due to degenerative sacroiliitis or SI joint disruptions.
Included in the presentation were initial results from ongoing 12-month follow-up. Of the 102 subjects randomized to iFuse, 12-month follow-up showed continued improvement in pain and disability scores. Of the 44 subjects randomized to NSM and still participating in the study, 34 crossed over to receive iFuse and 10 did not. All 34 crossover subjects underwent SI joint fusion with the iFuse Implant System. Initial results of twelve-month follow-up in this group showed marked improvements in pain and disability similar to those initially randomized to iFuse. Of the 10 subjects who did not crossover after 6 months, 12-month follow-up showed no further improvement in pain or disability.
“It is truly a great honor to receive the Leon L. Wiltse award for best overall paper at this year’s ISASS meeting and I would just like to congratulate and thank the other 18 clinical site investigators who participated in the trial as well the dozens of clinical support staff who’ve contributed to the quality and success of this study,” said Peter Whang, MD, FACS. Dr. Whang further commented: “I am impressed with the study’s preliminary 12-month results and, although follow-up is continuing, there is now very strong evidence that patients in the non-surgical group who crossed over to surgery after 6 months of continued non-surgical treatment had postoperative improvements in pain and disability almost as large as those initially assigned to SI joint fusion. Those who did not cross over had no further improvements in pain or disability. These results add to the validity of the study’s findings.”
Clinical publications have identified the SI joint as a pain generator in 15% to 30% of low back pain patients.1-4 In addition, the prevalence of SI joint pain in post-lumbar fusion, so called “failed back surgery” patients, has been shown to be up to 43%.5 Of these patients, some may have degenerative sacroiliitis or SI joint disruptions. Initial treatment options for patients with SI joint disorders typically involve non-surgical management and, when non-surgical management of the SI joint fails, surgical options such as the iFuse procedure may be considered.
SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for European commercialization was obtained in November 2010.
The iFuse Implant System is a minimally invasive surgical option that uses titanium implants coated with a porous, titanium plasma spray (TPS) that acts as an interference surface, designed to help decrease implant motion, provide immediate fixation and allow for biological fixation to support long term fusion. The iFuse System is intended for sacroiliac joint fusion for conditions including SI joint dysfunction that is a direct result of SI joint disruptions and degenerative sacroiliitis. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks.
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is the leading sacroiliac joint medical device company dedicated to the development of tools and products for patients with low back issues related to certain SI joint disorders. The company has developed, and is manufacturing and marketing, minimally invasive products for patients with certain SI joint disorders. SI-BONE has an experienced management team with extensive experience in orthopedic and spine medical devices. SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2015 SI-BONE, Inc. All Rights Reserved. 9197.051115
1 Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clinical Orthopedics and Related Research. 1987;217:266–80.
2 Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
3 Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
4 Sembrano JNa, Polly DW.a How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
5 DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Medicine. 2011;12:732-9.
Disclosures
a Investigators in a clinical research study sponsored by SI-BONE, but they have no financial interest in the company.
SOURCE SI-BONE, Inc.
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